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Immunoassays: Page 2
Researchers tweak TB treatment assay to support global use
By
Nick Paul Taylor
Researchers have developed a tuberculosis (TB) treatment assay that could be a faster, simpler method for monitoring patients.
April 10, 2024
BioMérieux gets FDA 510(k) clearance, CLIA waiver approval for panel
By
LabPulse.com staff writers
BioMérieux's Biofire Spotfire Respiratory/Sore Throat Panel has received dual FDA 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver approval.
March 27, 2024
CAP releases updated guideline for validation of IHC assays
By
LabPulse.com staff writers
The College of American Pathologists (CAP) has updated its evidence-based guideline for analytic validation of immunohistochemical assays to provide increased accuracy and consistency in laboratory practices.
February 26, 2024
High-sensitivity assay improves diagnosis for patients with heart muscle injury in U.K. study
By
Matt Limb
A high-sensitivity blood test can improve diagnosis for 1 in 5 patients who have a heart muscle injury, according to a U.K. hospital study.
December 6, 2023
Danaher cuts cost of rapid TB test after years of pressure from activists
By
Nick Paul Taylor
Danaher has cut the cost of one of its tuberculosis (TB) tests in less developed countries after years of public pressure to lower the price.
September 21, 2023
Day Zero Diagnostics awarded SBIR grant to develop fecal transplant safety assay
By
Matt Limb
Boston-based Day Zero Diagnostics is receiving research funding to support the development of a pharmacovigilance assay to enhance the safety and efficacy of fecal microbiota transplants (FMT) in clinical trials.
September 1, 2023
Proliferation of infectious disease tests leading to misuse and misinterpretation: Report
By
Nick Paul Taylor
The disconnect between changes in demand and capabilities can result in lab directors being asked to oversee testing that is outside of their areas of expertise. Additionally, there are more and more testing options.
July 28, 2023
Co-Diagnostics awarded over $2M from Bill & Melinda Gates Foundation for TB and HPV tests
By
Matt Limb
Dwight Egan, CEO of Co-Diagnostics, said the grants would help support the worldwide effort to prevent the spread of both TB and HPV in countries where they have been endemic killers for generations.
July 26, 2023
Siemens Healthineers adds compact testing system to its IVD portfolio
By
LabPulse.com staff writers
The Atellica CI analyzer has a 1.9 square meter footprint, making it ideal for smaller laboratories, but uses the same reagents, consumables, and Atellica Laboratory Evaluation Suite software as the company's Atellica Solution.
July 20, 2023
HPV point-of-care test in development combines isothermal amplification, lateral flow detection
By
LabPulse.com staff writers
A testing platform that combines the two technologies often used separately in diagnostic tests could simplify the equipment and procedures needed for HPV testing.
June 23, 2023
Qiagen describes systematic review for IGRA TB test, blood collection tubes
By
Leo O'Connor
The study including 4,050 subjects highlights the value of the TB2 tube and the detection of CD8 T-cell responses for immunocompromised patients, a key risk group for tuberculosis disease, the firm said.
June 15, 2023
Amid overdose epidemic, NIH and FDA seeking to reduce barriers to rapid drug-detection tools
By
LabPulse.com staff writers
The rapid detection tools often remain inaccessible because of gaps in research and other barriers, including state or legal prohibitions.
June 12, 2023
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